1480. Plasma and Urine Pharmacokinetic Analysis of Gepotidacin (GSK2140944) Following BID Oral Dosing in a Phase IIa Study for Treatment of Uncomplicated Urinary Tract Infections

2019 
Background Uncomplicated urinary tract infections (uUTIs) are very common, with approximately 11% of women >18 years of age experiencing at least 1 episode of acute cystitis per year [Foxman, 2000]. Multidrug resistance has now emerged at the community level and has made treatment approaches for UTIs more difficult [Hooton, 2012; Flamm, 2014; Sanchez, 2016]. Gepotidacin (GEP), a first-in-class, novel triazaacenaphthylene antibacterial has demonstrated in vitro activity against uropathogens, including E. coli. With its unique ability to selectively inhibit bacterial DNA replication by a means not utilized by any currently approved human therapeutic agent, GEP warrants further study as a potential opportunity to address an unmet medical need by providing a new and effective oral treatment option for acute cystitis.
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